EMA pilots scientific advice on clinical investigation of medical devices
The European Medicines Agency (EMA), which has coordinated the work of expert panels on medical devices since March 2022, will launch a pilot of giving scientific advice on clinical investigation as referred to in the MDR. The duration of the pilot will be approximately one year. The purpose of the service is stronger support for innovations in the EU and faster market access for safe and efficient devices.
The aim is for the manufacturer to be able to consult the expert panel on its clinical development strategy and proposals for clinical trials before implementation. Support will be provided to manufacturers of risk class III devices and certain class IIb devices. Manufacturers of devices of certain risk categories operating in the European Economic Area may apply for the pilot. Ten applicants to whom free advice on clinical development strategy and clinical trials will be offered will be selected for the pilot. In other words, the devices must still be at an early stage of development.
The pilot seeks devices on the broadest possible scale in different medical fields. EMA prioritises applications for devices that:
- benefit a relatively small group of patients, e.g. devices for paediatric use
- are intended for life-threatening situations or other serious situations for which there is currently insufficient treatment or the current treatments are particularly risky
- are new devices that provide significant clinical or health benefits.
The instructions and application form for the applicant have been published on the website of the European Medicines Agency (EMA).
At the end of the pilot, EMA will assess the functioning of the process and the experiences of applicants and experts in order to develop the process.
In addition to providing advice, the key responsibilities of the expert panels include supporting notified bodies in the review of clinical evaluation reports under the MD and IVD Regulations.
Further information on the topic:
EMA news item 27 February 2023: EMA pilots scientific advice for certain high-risk medical devices
- Hanna-Maria Matinolli, Coordinator, tel. +358 29 522 3244
- Minna Kymäläinen, Inspector, tel. +358 29 522 3279
- Fimea e-mail addresses are in the format firstname.lastname@example.org